search
Back to results

Characterization of Head and Neck Malignant Tumors Using an Electronic Nose (HNeNose)

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
collecting breath samples
Sponsored by
Carmel Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients with head and neck tumors
  2. A patient can understand, read and sign the informed consent form, signing a consent form
  3. Age over 18

Exclusion Criteria:

  1. Known or second primary head and neck cancer
  2. Surgery to head and neck index tumor except for tumor biopsy
  3. Unsteady comorbidity
  4. Pregnancy
  5. breastfeeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    eNose breath samples

    Arm Description

    Outcomes

    Primary Outcome Measures

    Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose).

    Secondary Outcome Measures

    Full Information

    First Posted
    March 20, 2013
    Last Updated
    July 30, 2015
    Sponsor
    Carmel Medical Center
    Collaborators
    Technion, Israel Institute of Technology
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01816919
    Brief Title
    Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
    Acronym
    HNeNose
    Official Title
    Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2010 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    September 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Carmel Medical Center
    Collaborators
    Technion, Israel Institute of Technology

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Head and neck tumors are common in the general population especially in high risk groups of smokers and alcohol abusers, as well as after exposure to various environmental factors. Diagnosis is based on identification of patients gross disease after a physical examination and various imaging methods, and characterization of tissue mainly by fine-needle puncture (FNA) and biopsy. Determining the stage of disease is based on physical examination, imaging and tissue samples. Using the electronic nose technology we hope to identify microscopic disease when it is suspected or in populations in risk, thus diagnose patients in the initial stages of the disease. Obviously, early diagnosis and treatment decisions will hopefully improve the prognosis. Finding a positive correlation between the stages, levels and various tumor volume and respiratory specimens findings will classify patients more accurately and contribute to further characterization of the disease in a more accurate, rapid and non-invasive fashion.
    Detailed Description
    Approximately 60,000 new cases of head and neck cancer are diagnosed in the U.S. each year, accounting for about 5% of cancer cases diagnosed in North America and approximately 1-2% of cancer deaths. Smoking and alcohol are the main risk factors for head and neck tumors and are recognized in 75% of cases. In contrast, consumption of fruits and vegetables was found to be a protective factor. The symptoms are varied and can include sore throat and / or neck, difficulty or pain in swallowing, difficulty in breathing and hoarseness, facial movement disorder and other. Multidisciplinary decision making and treatment is important for these patients due to the complexity of treatment and short-and long-term complications resulting from chemotherapy, radiotherapy and surgical intervention. About a third of patients are diagnosed with disease at stage 1 or 2. These patients are treated by surgery or radiation. Five years survival for patients diagnosed with stage I is around 90% and 70% for patients diagnosed with stage 2. Despite surgical and radiation treatment when patients present with locally advanced disease, only 30% -50% of them survive after five years. Therefore, many studies have been conducted in an attempt to improve prognosis. Improved results are seen in combination therapy with chemotherapy and radiation treatment. Patient survival depends on the stage of the disease, hence the importance of early detection. Research Laboratory of Dr. Hossam Haick developed a device that simulates the human nose. The device reveals patterns of volatile organic compounds emitted by breathing cancer cells. This is why it is referred to as "electronic nose". It includes an array of tiny nanometer sized sensors connected to an electronic computation unit. Because of their small size and electrical properties, the sensors are able to "smell" the changes in the composition of the materials that characterize cancer. Discovery of bio - cancer markers using breath samples offers several advantages: a) The breath samples are not invasive; b) air exhaled contains mixtures less complex than those found in blood or urine, and c) breath tests allow direct monitoring in real-time. In this study we want to test the reliability of the developed device in real clinical conditions. Another goal of these experiments is to characterize the differences between respiratory specimens for various disease stages and to examine whether there is a relationship between the results of the samples to tumor volume (calculated using diagnostic CT scans). Due to its simplicity, positive results will allow us to consider using the device as a screening device for head and neck cancer.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    eNose breath samples
    Arm Type
    Experimental
    Intervention Type
    Other
    Intervention Name(s)
    collecting breath samples
    Primary Outcome Measure Information:
    Title
    Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose).
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with head and neck tumors A patient can understand, read and sign the informed consent form, signing a consent form Age over 18 Exclusion Criteria: Known or second primary head and neck cancer Surgery to head and neck index tumor except for tumor biopsy Unsteady comorbidity Pregnancy breastfeeding

    12. IPD Sharing Statement

    Learn more about this trial

    Characterization of Head and Neck Malignant Tumors Using an Electronic Nose

    We'll reach out to this number within 24 hrs